Comparison of the effect of Agnogel, Simifogel and Suyagel, Vitagnos and S-citalopram drug in reducing menopausal symptoms of postmenopausal women.
Design
This study will be conducted in the form of a double-blind randomized clinical trial and the third phase of the trial with parallel groups, on 200 postmenopausal women who are referred to Isfahan Endocrine and Metabolism Research Center and specialist colleagues' office in Isfahan city. People are included in the study by available sampling method. The method of randomization, the random allocation of people to the studied groups will be completely random and will be done by Random Allocation software.
Settings and conduct
This study will be conducted as a double-blind randomized clinical trial on 200 postmenopausal women who refer to the Endocrine and Metabolism Research Center and Specialist Associates Clinic in Isfahan.
The participants, the co-investigator of the intervention effects, and the person analyzing the plan will be unaware of the allocation of people to groups and the type of medicine received.
Participants/Inclusion and exclusion criteria
Obtaining a score of 5 and above from the MRS questionnaire, 12 months or more have passed since menopause
Use of various hormonal drugs, use of drugs that interfere with the studied drugs. History of some diseases.
Intervention groups
The first group: one cimifugol coated tablet daily
The second group: one soyagol coated tablet daily
The third group: one Agnugol coated tablet daily
4th group: one Vitagnus coated tablet daily
The fifth group: one coated tablet of Escitalopram daily
Main outcome variables
Total score of menopausal symptoms; physical symptoms score; mental symptoms score; Urinary and genital symptoms score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080902001181N4
Registration date:2023-01-21, 1401/11/01
Registration timing:registered_while_recruiting
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Mansour Siavash
Name of organization / entity
Isfahan Endocrine and Metabolism Research Center
Country
Iran (Islamic Republic of)
Phone
+98 31 1222 0998
Email address
siavash@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-07, 1401/10/17
Expected recruitment end date
2023-04-06, 1402/01/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of Agnugol, Cimifugol , Soyagol , vitagnus and EsCitalopram in reducing menopausal symptoms in postmenopausal women
Public title
Comparison of the effect of Agnugol, Cimifugol , Soyagol , vitagnus and EsCitalopram
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining a score of 5 and above from the MRS questionnaire
12 months or more have passed since menopause
Age between 45 and 65 years
Exclusion criteria:
Presence or history of breast and uterine cancer, abnormal vaginal bleeding, liver, kidney, thyroid, depression and known anxiety disorders.
Use of progestins, contraceptive pills, GNRH agonists and antagonists
Taking drugs that interact with the studied drugs, such as warfarin, tamoxifen, antipsychotics, and dopamine antagonists.
Age
From 45 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
200
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, 200 eligible patients will be selected non-randomly and in the order of referral. Allocation of people to the five study groups will be done by "Random Allocation" specialized software and by Simple randomization method.
First, on the main page of the software, we enter the number of intervention groups (5 groups) and The name of interventions (based on the code defined for each type of intervention in advance) and the sample size (200 people). Then, by pressing the Generate random list button, a list according to the entered sample size (number 1 to 200) will be presented, which randomly specifies the type of each intervention (designated intervention code) for each person in the order of entering the study. to give Therefore, based on this list and in the order in which people enter the study, the person who distributes the drugs provides the relevant drug to the participants.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, 5 drugs "Agnugol", "Vitagnus", "soyagol", "cimifugol" and "EsCitalopram 10" are prepared and placed in coded packages and provided to the researcher.
He also provides the patient without knowing the type of any medicine. Also, the patient, the person recording the clinical and basic information of the patients, as well as the statistical analyst, will not be aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Isfahan University of Medical Sciences
Street address
Hezar jerib Street
City
Isfahan
Province
Isfehan
Postal code
8179964167
Approval date
2022-04-07, 1401/01/18
Ethics committee reference number
IR.ARI.MUI.REC.1401.097
Health conditions studied
1
Description of health condition studied
Menopause
ICD-10 code
N95.1
ICD-10 code description
Menopausal and female climacteric states
Primary outcomes
1
Description
Total score of menopausal symptoms
Timepoint
The total score of menopausal symptoms is checked at the beginning of the study (before the start of the intervention), the fourth and the eighth week after the start of the intervention.
Method of measurement
Menopause Rating Scale (MRS)
Secondary outcomes
empty
Intervention groups
1
Description
first intervention group: One CimiFugol coated tablet containing 6.5 mg of dry root of black cohosh plant manufactured by GolDaru Company will be taken daily for 8 weeks every night at a certain time with some water, preferably before going to bed.
Category
Treatment - Drugs
2
Description
second intervention group: One Agnugol coated tablet daily containing 4.8 mg of dry extract of the fruit of Vitex agnus-castus plant (standardized as 0.42-0.58 mg of Ecobin) manufactured by GolDaru Company for 8 weeks every night at a certain time with some water preferably before going to bed.
Category
Treatment - Drugs
3
Description
The third intervention group: once a day before meals, Vitagnus coated tablets containing Vitex agnus-castus plant (standardized as 1.2-3.3 mg of Ecobin) manufactured by Porsina Company will be consumed for 8 weeks.
Category
Treatment - Drugs
4
Description
4th intervention group: They take one Soyagol coated tablet containing 50 mg of soy isoflavone, manufactured by GolDaru Company, for 8 weeks every night at a certain time with some water after meals.
Category
Treatment - Drugs
5
Description
The fifth intervention group: take one 10 mg Escitalopram tablet daily after lunch for 8 weeks.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Endocrine Research Center (Sedigheh Tahereh)
Full name of responsible person
Mansour Siavash
Street address
Sedigheh Tahereh Center, Khorram Street, Jomhuri Eslami Square.
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3335 9933
Fax
Email
siavash@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
Endocrinologist
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Hezar Jerib Street
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 3668 8138
Fax
Email
siavash@med.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Khorram street, Jomhoori square
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 1222 0998
Fax
+98 31 1222 2255
Email
siavash@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Position
professor
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Khorram street, Jomhoori square
City
Isfahan
Province
Isfehan
Postal code
8187698191
Phone
+98 31 1222 0998
Fax
+98 31 1222 2255
Email
siavash@med.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD